Esophageal Squamous Cell CarcinomasPhase 2RICENCT05621707
Chemoradiotherapy Following Immunotherapy Plus Chemotherapy for Locally-advanced Esophageal Squamous Cell Cancer (RICE)
A Phase 2 study testing chemotherapy combined with PD-1 inhibitors in people with Esophageal Squamous Cell Carcinomas and Concurrent Chemoradiotherapy, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
This is an investigator-initiated, single-arm, exploratory clinical study.The study population consisted of non-operative Locally Advanced Esophageal Cancer . The purpose of this study was to evaluate the efficacy and safety of Concurrent Chemoradiotherapy Following Immunotherapy Plus Chemotherapy for Patients With… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Squamous Cell Carcinomas, Concurrent Chemoradiotherapy, Immunotherapy
- What is being tested?
- chemotherapy combined with PD-1 inhibitors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 2 Nov 2022to Oct 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 18 years at the time of screening.
- Histologically confirmed squamous cell carcinoma;
- Locally-advanced ,medical inoperability, technical irresectability, or patient refusal to surgery;
- Eastern Cooperative Oncology Group (ECOG) performance status:0-2;
- Able to eat a semi-liquid diet;
- Less than 20% weight loss within 6 months;
- Adequate hepatic function, renal function, hematologic function and coagulation function;
- Documented informed consent.
Who cannot join
- Distant metastasis;
- Known malignancy diagnosed or require active treatment in the last 5 years, except for cancers that can be cured by surgery including cervical cancer in situ, basal or squamous cell skin cancer, breast ductal carcinoma in situ, localized prostate cancer;
- Prior thoracic irradiation, chemotherapy, or lobectomy
- Known diseases or conditions that are contraindicated for radiotherapy or surgery;
- Allergy to the research medications;
- Pregnant women or women preparing for pregnancy;
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- Diagnosis of autoimmune disease or history of chronic autoimmune disease
- Absence of informed consent because of psychological, family, social and other factors;
- Patients with comorbidities (chronic pulmonary disease, poorly controlled hypertension, unstable angina, myocardial infarction within 6 months, unstable mental disorders requiring therapy).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2 Trial of Concurrent Chemoradiotherapy Following Immunotherapy Plus Chemotherapy for Patients With Locally-advanced Esophageal Squamous Cell Cancer
This is an investigator-initiated, single-arm, exploratory clinical study.The study population consisted of non-operative Locally Advanced Esophageal Cancer . The purpose of this study was to evaluate the efficacy and safety of Concurrent Chemoradiotherapy Following Immunotherapy Plus Chemotherapy for Patients With Locally-advanced Esophageal Squamous Cell Cancer.
- Conditions
- Esophageal Squamous Cell Carcinomas, Concurrent Chemoradiotherapy, Immunotherapy, Chemotherapy
- Being tested
- chemotherapy combined with PD-1 inhibitors
- Keywords
- esophageal cancer, chemoradiotherapy, immunotherapy, chemotherapy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemotherapy combined with PD-1 inhibitorsDrug
Induction chemotherapy combined with PD-1 inhibitors followed with standard concurrent chemoradiotherapy
| Study group | Role | What they receive |
|---|---|---|
| experimental arm | Experimental | Induction Therapy: Two cycles of induction chemotherapy (nab-paclitaxel 200 mg/m², day 1; carboplatin AUC 5, day 1) combined with a PD-1 inhibitor (200 mg, day 1) every 3 weeks.
Concurrent Therapy: Followed by concurrent chemoradiotherapy (CCRT).
Maintenance Therapy: Patients without progressive disease (PD) will receive maintenance immunotherapy with a PD-1 inhibitor (200 mg every 3 weeks) for up to 1 year. Receives: Drug: chemotherapy combined with PD-1 inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival Rate
Overall survival rate is defined as the percentage of participants who are alive up to 2 years from enrollment
Measured: 2 years after last patient enrolled
Secondary outcomes (2)
progression-free Survival (PFS)
Progression-free survival is defined as the time between date of enrollment and first date of recurrence or death, whichever occurs first.Recurrence is defined as the appearance of one or more new lesions, which can be local, regional, or distant in location from the primary tumor site ( assessed by imaging or pathology). All deaths without prior recurrence are considered as PFS events.
Measured: 2 years after last patient enrolled
Treatment related complications
complications after treatment
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start2 Nov 2022
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomasStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Liu, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05621707
- Sponsor's protocol ID
- drjunliu
- Acronym
- RICE
- Status last verified
- Jan 2026
- First submitted
- 5 Nov 2022
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Trial of Concurrent Chemoradiotherapy Following Immunotherapy Plus Chemotherapy for Patients With Locally-advanced Esophageal Squamous Cell Cancer
- ClinicalTrials.gov ID
- NCT05621707
- Acronym / sponsor ID
- RICE / drjunliu
- Conditions
- Esophageal Squamous Cell Carcinomas, Concurrent Chemoradiotherapy, Immunotherapy, Chemotherapy
- Keywords
- esophageal cancer, chemoradiotherapy, immunotherapy, chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 18 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an investigator-initiated, single-arm, exploratory clinical study.The study population consisted of non-operative Locally Advanced Esophageal Cancer . The purpose of this study was to evaluate the efficacy and safety of Concurrent Chemoradiotherapy Following Immunotherapy Plus Chemotherapy for Patients With Locally-advanced Esophageal Squamous Cell Cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental arm | Experimental | Drug: chemotherapy combined with PD-1 inhibitorsInduction Therapy: Two cycles of induction chemotherapy (nab-paclitaxel 200 mg/m², day 1; carboplatin AUC 5, day 1) combined with a PD-1 inhibitor (200 mg, day 1) every 3 weeks. Concurrent Therapy: Followed by concurrent chemoradiotherapy (CCRT). Maintenance Therapy: Patients without progressive disease (PD) will receive maintenance immunotherapy with a PD-1 inhibitor (200 mg every 3 weeks) for up to 1 year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged ≥ 18 years at the time of screening.
- Histologically confirmed squamous cell carcinoma;
- Locally-advanced ,medical inoperability, technical irresectability, or patient refusal to surgery;
- Eastern Cooperative Oncology Group (ECOG) performance status:0-2;
- Able to eat a semi-liquid diet;
Key exclusion criteria (9 listed)
- Distant metastasis;
- Known malignancy diagnosed or require active treatment in the last 5 years, except for cancers that can be cured by surgery including cervical cancer in situ, basal or squamous cell skin cancer, breast ductal carcinoma in situ, localized prostate cancer;
- Prior thoracic irradiation, chemotherapy, or lobectomy
- Known diseases or conditions that are contraindicated for radiotherapy or surgery;
- Allergy to the research medications;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chemotherapy combined with PD-1 inhibitorsInduction chemotherapy combined with PD-1 inhibitors followed with standard concurrent chemoradiotherapy | Drug | experimental arm |
Primary outcome
Overall Survival Rate
Time frame: 2 years after last patient enrolled
Overall survival rate is defined as the percentage of participants who are alive up to 2 years from enrollment
2 secondary outcomes
progression-free Survival (PFS)
Time frame: 2 years after last patient enrolled
Treatment related complications
Time frame: During the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing chemotherapy combined with PD-1 inhibitors in people with Esophageal Squamous Cell Carcinomas and Concurrent Chemoradiotherapy, run by Shanghai Chest Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival Rate (time frame: 2 years after last patient enrolled). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.